|Title||PharmAbcine Receives IND Approval from the Korean MFDS for Phase I Clinical Trial of Its Novel TIE2 Agonistic Antibody in nAMD|
PharmAbcine Receives IND Approval from the Korean MFDS for Phase I Clinical Trial of Its Novel TIE2 Agonistic Antibody in nAMD
DAEJEON, South Korea, May 23, 2023 /PRNewswire/ -- PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next-generation antibody therapeutics, announced today that the Company received IND (Investigational New Drug) approval from the Korean MFDS (Ministry of Food and Drug Safety) to initiate a Phase I clinical trial of PMC-403, the Company’s novel TIE2 agonistic antibody.
The Phase I clinical trial is an open-label, multi-center, single and multiple ascending-dose study to assess safety, tolerability, MTD (maximum tolerated dose), RP2D (recommended phase 2 dose), and as well as clinical efficacy and pharmacokinetics of PMC-403 in subjects with nAMD (neovascular age-related macular degeneration). The study will take place in multiple hospitals in South Korea, including Seoul National University Bundang Hospital.
PMC-403 is a first-in-class antibody that activates TIE2, a receptor specifically expressed in vascular endothelial cells. Once the molecule binds to the receptors, it promotes the normalization and stabilization of pathologically leaky blood vessels. The Company has been developing this asset as a new potential therapeutic drug for neovascular ocular diseases, including AMD (Age-related Macular Degeneration), DME (Diabetic Macular Edema), and DR (Diabetic Retinopathy), all of which are the leading causes of blindness.
PharmAbcine already announced that PMC-403, even with its unique mechanism, reduced the size of retinal leakages in both mouse and monkey models comparable to a control group treated with aflibercept, the best-selling anti-VEGF drug in the current market. The Company also reported no safety issues found in multiple dosing groups from IND-enabling studies in April 2022.
“We are pleased to be granted IND approval of PMC-403 for the treatment of nAMD, one of the most prevalent neovascular ocular diseases,” said Dr. Jin-San Yoo, CEO of PharmAbcine. “PMC-403 marks the world’s first TIE2 agonistic antibody being approved for an ophthalmology clinical trial, and we are hopeful that it will be able to provide a new therapeutic option for patients, who do not respond or have become relapsed to the existing anti-VEGF drugs. Our members are eagerly awaiting the start of this important study and start generating encouraging data.”
nAMD (neovascular age-related macular degeneration) is an advanced form of macular degeneration, an acquired degeneration of the retina that results in significant central vision loss due to neovascular and non-neovascular damages. It has been known to be the leading cause of AMD-related vision loss.
About PharmAbcine Inc.
PharmAbcine is a clinical stage public company developing next generation IgG based therapeutics to treat cancer, neovascular eye diseases, and vascular related unmet needs.
The Company’s main pipeline assets include olinvacimab, the lead asset in clinical stage, and IND-ready preclinical assets with first-in-class potential such as PMC-309 and PMC-403.
Olinvacimab, the Company’s lead asset, is undergoing a Phase II trial in combination with MSD’s pembrolizumab for mTNBC patients in Australia. The Company entered the Phase II study to reconfirm the encouraging result from Phase Ib olinvacimab-pembrolizumab trial, delivering 50% ORR, 67% DCR, and clean safety profile.
PMC-309, a novel anti-VISTA-antagonizing IgG in pan pH, is an immune checkpoint regulator that targets MDSC (myeloid derived suppressor cells) and M2 macrophages which play pivotal role in maintaining immunosuppressive TME (Tumor Microenvironment).
PMC-403 is a novel TIE2-activating antibody that stabilizes dysfunctional leaky disorganized pathological vessels and can be used for vascular-related eye disease, including wet AMD (Age-related Macular Degeneration).
One of other early-stage assets, PMC-005, is an anti-EGFRviii IgG that only binds to EGFRviii expressed on cancer cells and can be applied to various modalities including CAR-T, CAR-NK, CAR-Macrophage, T cell/NK cell engager, and Radio-Immunotherapy
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